-Ownership, oversight, and impact on local regulatory and financial compliance-Responsible for quality and compliance in assigned protocols in the country. Contributes to development of local SOPs (Standard Operation Procedures)-Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols, development of local language materials including local language Informed Consents and translations-Collaborates closely with Regional… Show more -Ownership, oversight, and impact on local regulatory and financial compliance-Responsible for quality and compliance in assigned protocols in the country. Contributes to development of local SOPs (Standard Operation Procedures)-Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols, development of local language materials including local language Informed Consents and translations-Collaborates closely with Regional Operations and/or Headquarters to align country timelines for assigned protocols-Provides support and oversight to local vendors Show less

-Accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally.-Additional function as Subject Matter Expert for Essential Documents Management and Veeva Vault.

-Accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally.-Additional function as Subject Matter Expert for Essential Documents Management and Veeva Vault.